Effectiveness of Messages to Mobile Phone in Smoke Cessation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01746069|
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : October 21, 2015
Smoking remains a major risk factor for chronic diseases and is a real problem for health systems. The use of emerging technologies, such as mobile phone , may have a important role in smoking cessation programs through sending reinforcement messages when patients quits smoking.
Main objective: To evaluate the effectiveness of a combined 6 months smoking cessation program including health advice provided by a doctor and sending support messages to mobile phone of patients.
Methods: Study design: Randomized single blind clinical trial. Study population: Patients over 18 who are willing to start a smoking cessation program, who have mobile phone, who are able to receive and send messages, and who have a score greater than 5 or equal to 5 on the Richmond scale.
Sample size: 160 patients per arm to detect a difference in the percentage of smoking cessation than 10% (14.9% vs. 4.9%) between the two groups. Intervention: Experimental group: Health advice and support messages to mobile phone patients.
Control group: Health advice. Assessment of the primary endpoint: At 6 months (positive/negative coximetry test).
Statistical analysis: The analysis of the primary endpoint (positive / negative coximetry test) will be performed using logistic regression.
|Condition or disease||Intervention/treatment||Phase|
|Smoking||Behavioral: Quit smoking combined cessation programme Behavioral: health advice||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evaluation of a Reinforcement Program Using Text Messages Through Mobile Phone in Smoking Cessation Programs in Primary Care|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||October 2015|
Placebo Comparator: health advice
clinical practice routine
Behavioral: health advice
routine clinical practice
Experimental: Quit smoking combined cessation programme
Health advice and support sms messages to patient's mobile phone + clinical routine practice
Behavioral: Quit smoking combined cessation programme
Support sms messages to patient's mobile phone and health advice
- Coximetry test (positive/negative) [ Time Frame: at 6 months ]
- Continuous abstinence at 6 months: Yes / No [ Time Frame: At 6 months ]Continuous Abstinence is defined as smoking more than 5 cigarettes since the beginning of the follow-up period self-reported by the patient.
- Abstinence point during the first 7 days self-reported by the patient: Yes / No. [ Time Frame: at first week ]Abstinence is defined as not smoking anything punctual during the last seven days.
- -Prevalence abstinence at the 4th week self-reported by the patient: Yes / No. [ Time Frame: At 4th week ]
- -Prevalence abstinence at 12th week self-reported by the patient: Yes / No. [ Time Frame: At 12th week ]
- -Outcome of coxymetry test at 12 months of start: Positive / Negative. [ Time Frame: at 12 months ]Only in patients with a negative result in the 6 months test
- Number of messages requested by the patient anxiety. [ Time Frame: at 12 months ]
- slip: Yes / No. [ Time Frame: at 12 months ]Treated as the first use (consumption point) after a period of abstinence
- - Relapse: Yes / No. [ Time Frame: At 12 months ]Relapse is defined to return dependent behavior that had tried to change, recovering or not the baseline levels before treatment.
- Number of messages relapse-slip timely requested by the patient. [ Time Frame: At 12 months ]
- other variables [ Time Frame: at baseline ]Sex (male / female), age (years), number of cigarettes per day before starting program, age of start smoking (years), smoke related pathology (Yes/No), score on the anxiety scale Goldberg, previous attempts to quit smoking (Yes / No if yes, specify number of attempts and reasons for relapse), ), smoking dependence fagerström test score), type of smoker (occasional / daily).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746069
|Health centre Lakuabizkarra|
|Vitoria-Gasteiz, Alava, Spain, 01009|